{"id":30497,"date":"2026-01-22T10:11:54","date_gmt":"2026-01-22T09:11:54","guid":{"rendered":"https:\/\/kymos.com\/news\/usp-materials-extraibles-i-lixiviables-en-sistemes-d39un-sol-us\/"},"modified":"2026-04-14T13:48:00","modified_gmt":"2026-04-14T11:48:00","slug":"usp-materials-extraibles-i-lixiviables-en-sistemes-d39un-sol-us","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/usp-materials-extraibles-i-lixiviables-en-sistemes-d39un-sol-us\/","title":{"rendered":"USP<665> \/<1665> Materials extra\u00efbles i lixiviables en sistemes d&#8217;un sol \u00fas"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">Els sistemes d&#8217;un sol \u00fas (SUS) s&#8217;han convertit en una part integral de la fabricaci\u00f3 biofarmac\u00e8utica moderna. Els components basats en pol\u00edmers ofereixen flexibilitat, requisits de neteja redu\u00efts i canvis de proc\u00e9s m\u00e9s r\u00e0pids, i s&#8217;utilitzen en molts escenaris, com ara bioreactors aig\u00fces amunt, filtraci\u00f3 aig\u00fces avall o conjunts d&#8217;ompliment. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Simult\u00e0niament, el seu \u00fas extensiu ha refor\u00e7at la import\u00e0ncia de l&#8217;avaluaci\u00f3 de les seves subst\u00e0ncies <strong>extra\u00efbles i lixiviables (E&amp;L)<\/strong> . Per garantir la qualitat del producte, la seguretat del pacient i el compliment normatiu, \u00e9s crucial comprendre i gestionar qualsevol interacci\u00f3 qu\u00edmica entre els productes d&#8217;un sol \u00fas i els processos de producci\u00f3. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Amb la introducci\u00f3 dels nous cap\u00edtols generals de la USP <strong>&lt;665&gt;<\/strong> i <strong>&lt;1665&gt;<\/strong> , les expectatives sobre els estudis d&#8217;extra\u00efbles i lixiviables (E&amp;;L) per a sistemes d&#8217;un sol \u00fas s\u00f3n cada cop m\u00e9s clares i estructurades. Per als fabricants de productes biol\u00f2gics, aix\u00f2 representa tant una fita reguladora com una oportunitat per enfortir les estrat\u00e8gies de CMC basades en el risc. <\/span><\/p>\n<h2><strong>Sistemes d&#8217;un sol \u00fas en biofarmac\u00e8utica: beneficis i reptes dels estudis d&#8217;E&amp;L<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Les tecnologies d&#8217;un sol \u00fas estan \u00e0mpliament establertes en la fabricaci\u00f3 de productes biol\u00f2gics, permetent un disseny flexible d&#8217;instal\u00b7lacions, reduint els riscos de neteja i contaminaci\u00f3 creuada i permetent operacions d&#8217;escalat r\u00e0pid o multiproducte. En el processament aig\u00fces amunt i aig\u00fces avall, components com ara bosses, tubs, connectors, filtres i bioreactors d&#8217;un sol \u00fas s&#8217;integren rutin\u00e0riament en els fluxos de treball de fabricaci\u00f3. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Tanmateix, a difer\u00e8ncia dels equips tradicionals d&#8217;acer inoxidable o vidre, els components d&#8217;un sol \u00fas solen estar fets de <strong>materials polim\u00e8rics complexos<\/strong> que poden contenir additius com ara antioxidants, plastificants, estabilitzadors, pigments o coadjuvants de processament. Depenent de les condicions d&#8217;\u00fas, certes subst\u00e0ncies poden migrar del material al flux de proc\u00e9s, amb el potencial d&#8217;afectar la qualitat o la seguretat del producte si no s&#8217;avaluen adequadament. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Aquesta migraci\u00f3 potencial \u00e9s la base de les preocupacions <strong>sobre els materials extra\u00efbles i lixiviables<\/strong> :<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Els extra\u00efbles<\/strong> s\u00f3n compostos que es poden alliberar dels materials en condicions exagerades o for\u00e7ades.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Els lixiviables<\/strong> s\u00f3n compostos que realment migren a la subst\u00e0ncia o producte farmac\u00e8utic en condicions <span style=\"text-decoration: line-through;\">reals<\/span> de proc\u00e9s o emmagatzematge.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">En el context dels productes biol\u00f2gics, fins i tot les impureses de baix nivell poden afectar <strong>els atributs cr\u00edtics de qualitat<\/strong> , com ara l&#8217;estabilitat, la seguretat i l&#8217;efic\u00e0cia, cosa que fa que l&#8217;avaluaci\u00f3 d&#8217;E&amp;L sigui una part clau de la comprensi\u00f3 i el control del proc\u00e9s.<\/span><\/p>\n<h2><strong>What are USP &lt;665&gt; and &lt;1665&gt;?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Cap\u00edtols de la USP&lt; 665&gt; i&lt; 1665&gt; es van desenvolupar per abordar els riscos d&#8217;emerg\u00e8ncia i p\u00e8rdua (E&amp;L) associats amb <strong>els components i sistemes de pl\u00e0stic utilitzats en la fabricaci\u00f3 farmac\u00e8utica i biofarmac\u00e8utica<\/strong> .<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>USP&lt; 665&gt;<\/strong> \u00e9s un <strong>cap\u00edtol general obligatori<\/strong> que defineix enfocaments estandarditzats per avaluar materials extra\u00efbles de components i sistemes de pl\u00e0stic. La seva data d&#8217;entrada en vigor oficial \u00e9s l&#8217;1 de <strong>maig de 2026<\/strong> . <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>USP&lt; 1665&gt;<\/strong> \u00e9s un <strong>cap\u00edtol d&#8217;orientaci\u00f3<\/strong> que descriu els principis d&#8217;avaluaci\u00f3 de riscos i disseny d&#8217;estudis que donen suport a les avaluacions d&#8217;E&amp;L en virtut de&lt; 665&gt; .<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">A la pr\u00e0ctica,&lt; 665&gt; defineix <em>qu\u00e8<\/em> s&#8217;ha de fer, mentre&lt; 1665&gt; explica <em>com<\/em> aplicar aquests requisits amb un enfocament cient\u00edficament s\u00f2lid i basat en el risc.<\/span><\/p>\n<h2><strong>\u00c0mbit d&#8217;aplicaci\u00f3 de la USP&lt; 665&gt; i&lt; 1665&gt;<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">USP&lt; 665&gt; s&#8217;aplica a components i sistemes de pl\u00e0stic que entren en <strong>contacte directe amb fluxos de proc\u00e9s<\/strong> , intermedis, subst\u00e0ncies farmacol\u00f2giques o productes farmacol\u00f2gics. Exemples t\u00edpics inclouen: <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Bosses i folres d&#8217;un sol \u00fas<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Filtres i conjunts de filtraci\u00f3<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Tubs i connectors<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Agulles d&#8217;ompliment i components de transfer\u00e8ncia de fluids<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Sistemes de mescla i bioreactors d&#8217;un sol \u00fas<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Els elements sense contacte amb fluids o amb una exposici\u00f3 insignificant generalment queden fora de l&#8217;abast, cosa que refor\u00e7a la import\u00e0ncia de <strong>l&#8217;avaluaci\u00f3 espec\u00edfica del proc\u00e9s<\/strong> en lloc de proves generals o &#8220;generals&#8221;.<\/span><\/p>\n<h2><strong><span style=\"font-size: 18pt;\">Per qu\u00e8 aix\u00f2 importa ara<\/span><\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">La data d&#8217;entrada en vigor oficial \u00e9s a prop i els fabricants ja s&#8217;estan preparant per a les inspeccions i auditories d&#8217;acord amb els nous cap\u00edtols. En paral\u00b7lel, els esfor\u00e7os d&#8217;harmonitzaci\u00f3 global com ara <strong>l&#8217;ICH Q3E<\/strong> estan configurant les futures expectatives reguladores al voltant de l&#8217;E&amp;L. Podeu llegir m\u00e9s informaci\u00f3 sobre la nova guia al nostre article anterior sobre l&#8217; <a href=\"https:\/\/kymos.com\/ca\/news\/extraibles-i-lixiviables-analisi-disseny-destudi-i-guia-ich-q3e\/\" data-wpel-link=\"internal\">an\u00e0lisi, el disseny de l&#8217;estudi i la guia ICH Q3E.<\/a> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Aquests desenvolupaments paral\u00b7lels apunten en la mateixa direcci\u00f3: l&#8217;avaluaci\u00f3 d&#8217;E&amp;L per a sistemes d&#8217;un sol \u00fas est\u00e0 m\u00e9s enll\u00e0 d&#8217;un exercici opcional o cas per cas i s&#8217;est\u00e0 integrant cada cop m\u00e9s com a element est\u00e0ndard de les estrat\u00e8gies de CMC dels productes biol\u00f2gics.<\/span><\/p>\n<h2><strong>L&amp;#39;enfocament basat en el risc en estudis de materials extra\u00efbles i lixiviables<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Els estudis sobre materials extra\u00efbles estan dissenyats per generar un <strong>perfil qu\u00edmic<\/strong> de possibles migrants exposant els materials a dissolvents seleccionats en condicions controlades i sovint exagerades. Aquests estudis ajuden a identificar compostos que <em>podrien<\/em> convertir-se en lixiviables. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Els lixiviables, en canvi, s&#8217;avaluen en <strong>condicions realistes de proc\u00e9s o producte<\/strong> i representen compostos que <em>realment<\/em> migren al producte. Com a tals, proporcionen informaci\u00f3 directa sobre l&#8217;exposici\u00f3 rellevant per al pacient. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">USP&lt; 665&gt; i&lt; 1665&gt; emfatitzar que les dades extra\u00efbles s\u00f3n una <strong>eina per a l&#8217;avaluaci\u00f3 de riscos<\/strong> , no una finalitat en si mateixes.<\/span><\/p>\n<h2><strong>Classificaci\u00f3 de riscos segons la USP&lt; 665&gt; \/&lt; 1665&gt;<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Un element central del marc de la USP \u00e9s <strong>la classificaci\u00f3 de riscos<\/strong> , que considera:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Naturalesa del material i additius<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Composici\u00f3 del flux de proc\u00e9s<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Fase d&#8217;\u00fas (aig\u00fces amunt, aig\u00fces avall, ompliment)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Temps de contacte i temperatura<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Capacitat de les etapes de purificaci\u00f3 posteriors per eliminar possibles lixiviables<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">A partir d&#8217;aquesta avaluaci\u00f3, els components es poden classificar com a de risc baix, mitj\u00e0 o alt, la qual cosa influeix directament en l&#8217; <strong>abast i la complexitat de les proves anal\u00edtiques<\/strong> necess\u00e0ries.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En lloc d&#8217;aplicar proves del pitjor dels casos a cada component, l&#8217;enfocament USP fomenta <strong>estudis espec\u00edfics i basats en la ci\u00e8ncia<\/strong> . Aix\u00f2 permet als fabricants centrar els recursos on l&#8217;impacte potencial en la qualitat del producte o la seguretat del pacient \u00e9s m\u00e9s alt, una consideraci\u00f3 particularment important en els processos complexos de fabricaci\u00f3 de productes biol\u00f2gics. <\/span><\/p>\n<h2><strong>Disseny d&#8217;estudi E&amp;L per a sistemes d&#8217;un sol \u00fas<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Un programa robust d&#8217;E&amp;L per a SUS normalment segueix un <strong>enfocament gradual<\/strong> :<\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"><strong>Avaluaci\u00f3 de materials i processos<\/strong><\/span><br \/>\n<span style=\"font-size: 14pt;\">Comprensi\u00f3 de la composici\u00f3 dels pol\u00edmers, els processos de fabricaci\u00f3 i les condicions d&#8217;\u00fas, a la llum de la informaci\u00f3 proporcionada pel fabricant.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Proves d&#8217;extra\u00efbles<\/strong><\/span><br \/>\n<span style=\"font-size: 14pt;\">\u00das de dissolvents seleccionats i condicions alineades amb la USP&lt; 665&gt; per crear perfils qu\u00edmics representatius.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Cribratge anal\u00edtic<\/strong><\/span><br \/>\n<span style=\"font-size: 14pt;\">Aplicaci\u00f3 de t\u00e8cniques ortogonals com ara GC-MS, LC-MS i ICP-MS per identificar impureses vol\u00e0tils, semivol\u00e0tils, no vol\u00e0tils i elementals.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Interpretaci\u00f3 de dades i avaluaci\u00f3 de riscos<\/strong><\/span><br \/>\n<span style=\"font-size: 14pt;\">Avaluaci\u00f3 de les troballes en el context de l&#8217;exposici\u00f3 al proc\u00e9s, la capacitat de purificaci\u00f3 i la rellev\u00e0ncia toxicol\u00f2gica.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt;\">Quan sigui necessari, les dades d&#8217;extra\u00efbles poden donar suport <strong>a estudis de simulaci\u00f3 o lixiviables<\/strong> en condicions espec\u00edfiques del proc\u00e9s.<\/span><\/p>\n<h2><strong><span style=\"font-size: 18pt;\">Llindar d&#8217;Avaluaci\u00f3 Anal\u00edtica (AET)<\/span><\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">El llindar d&#8217;avaluaci\u00f3 anal\u00edtica (AET) no \u00e9s un valor fix, sin\u00f3 que es basa en factors com l&#8217;exposici\u00f3 del proc\u00e9s, la dosi, la via d&#8217;administraci\u00f3 i les consideracions de seguretat del pacient. Com a resultat, els <span style=\"text-decoration: line-through;\">AET<\/span> s&#8217;han d&#8217;interpretar dins del context del proc\u00e9s de fabricaci\u00f3 espec\u00edfic i del producte en desenvolupament. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Aix\u00f2 refor\u00e7a la import\u00e0ncia de dissenyar estudis d&#8217;E&amp;L que s&#8217;adaptin a l&#8217;\u00fas previst del sistema d&#8217;un sol \u00fas, en lloc de basar-se \u00fanicament en criteris d&#8217;acceptaci\u00f3 gen\u00e8rics que poden no reflectir adequadament les condicions reals del proc\u00e9s.<\/span><\/p>\n<h2><strong>Qu\u00e8 significa aix\u00f2 per als fabricants de productes biol\u00f2gics<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Per als desenvolupadors i fabricants de productes biol\u00f2gics, l&#8217;avaluaci\u00f3 d&#8217;electrolisi i embalatge (E&amp;L) dels sistemes d&#8217;un sol \u00fas t\u00e9 implicacions directes per a:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Robustesa i consist\u00e8ncia del proc\u00e9s<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Qualificaci\u00f3 de prove\u00efdors i selecci\u00f3 de materials<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Presentacions normatives i preparaci\u00f3 per a auditories<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Gesti\u00f3 del cicle de vida del producte a llarg termini<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Integrar les consideracions d&#8217;E&amp;L al principi del desenvolupament ajuda a reduir el risc de troballes en etapes avan\u00e7ades, afavoreix una presa de decisions m\u00e9s informada i facilita interaccions m\u00e9s fluides amb les autoritats reguladores a mesura que evolucionen els processos.<\/span><\/p>\n<h2><strong>Com Kymos aborda l&#8217;E&amp;L per a sistemes d&#8217;un sol \u00fas<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">A Kymos, els estudis d&#8217;E&amp;L per a sistemes d&#8217;un sol \u00fas es dissenyen amb una <strong>mentalitat basada en el risc i centrada en la ci\u00e8ncia<\/strong> . Cada programa es personalitza segons el proc\u00e9s, el material i el context regulador espec\u00edfics, en lloc de seguir un enfocament general. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Les nostres capacitats inclouen la creaci\u00f3 de perfils exhaustius d&#8217;extra\u00efbles mitjan\u00e7ant t\u00e8cniques anal\u00edtiques avan\u00e7ades, combinades amb una interpretaci\u00f3 estructurada de dades alineada amb les expectatives reguladores actuals. En integrar els estudis d&#8217;E&amp;L dins d&#8217;estrat\u00e8gies CMC m\u00e9s \u00e0mplies, donem suport als fabricants de productes biol\u00f2gics en la generaci\u00f3 <strong>de dades fiables i accionables<\/strong> que compleixin les expectatives reguladores. <\/span><\/p>\n<h2><strong>Conclusi\u00f3<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">A mesura que els sistemes d&#8217;un sol \u00fas tenen un paper m\u00e9s important en la fabricaci\u00f3 de productes biol\u00f2gics, l&#8217;avaluaci\u00f3 dels extractables i lixiviables \u00e9s ara una part clau de la qualitat i el compliment. USP&lt; 665&gt; i&lt; 1665&gt; oferir una guia clara per gestionar aquests riscos amb m\u00e8todes estructurats i basats en el risc. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En saber qu\u00e8 esperen els reguladors i utilitzar estrat\u00e8gies d&#8217;E&amp;L basades en la ci\u00e8ncia, els fabricants poden millorar el control de processos, ajudar en les sol\u00b7licituds reglament\u00e0ries i, en \u00faltima inst\u00e0ncia, garantir la seguretat i la qualitat dels seus productes. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Si necessiteu ajuda amb els vostres estudis d&#8217;extra\u00efbles i lixiviables, o amb qualsevol dels vostres estudis de CMC o bioanal\u00edtics, poseu-vos en contacte amb nosaltres o envieu-nos un correu electr\u00f2nic a commercial@kymos.com<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Els sistemes d&#8217;un sol \u00fas (SUS) s&#8217;han convertit en una  [&#8230;]<\/p>\n","protected":false},"author":8,"featured_media":30484,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-30497","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>USP 665: estraibili e lixiviabili nei sistemi monouso<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre les noves USP 665 i 1665 i com afecten els materials extra\u00efbles i lixiviables per a sistemes d&#039;un sol \u00fas.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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